Heart Failure Clinical Trial
Official title:
Management of the Patient With Heart Failure and Diabetes: May Insulin be a Problem? A Pilot Randomized Clinical Study (Insulin-HF)
Cardiac failure (HF) and type 2 diabetes mellitus (T2DM) are two clinical conditions with a
significant impact on public health worldwide. In the elderly population the prevalence of
T2DM is constantly increasing as well as its incidence in all Western countries including
Italy. The combination of HF and T2DM is frequent and leads to an increased risk of death and
of non-fatal adverse cardiovascular (CV) events which justifies the frailty of this
population. Although diabetic patients (pts) with HF respond to recommended treatments for
HF, the effective and safe control of blood glucose levels is still an outstanding clinical
problem, since glucose lowering drugs may increase the risk of CV adverse events. Insulin,
used in about 30% of diabetic patients with HF, causes adverse effects such as fluid and
sodium retention and unwanted effects of hypoglycemia. Even if insulin remains a milestone in
glucose lowering therapy of T2DM, its risk/benefit ratio is still controversial, more so when
given to old patients with HF. The issue has gained relevance since new antidiabetic agents,
as the sodium glucose co-transporter 2 (SGLT- 2) inhibitors and glucagon-like peptide (GLP-1)
analogues, with a safer CV profile have been made available. While the transferability of the
CV benefits attributed to the new drugs needs to be assessed in clinical practice, the
present study explore the benefit/risk profile of insulin in HF.
Objectives: to assess comparatively in patients with heart failure and T2DM the benefit/risk
profile over 1-year follow-up of two antidiabetic strategies, standard care with vs without
insulin in terms of humoral and clinical endpoints including body weight change, all-cause
mortality and burden of care components (hospitalizations for CV events and episodes of
severe hypoglycemia).
The project will consist in a controlled, randomized, open-label (PROBE design) multicenter,
pilot study. Central randomization stratified by center, performed online, will allow a
comparison of two groups of patients one receiving standard care including insulin, the other
standard care without insulin. Patients considered not eligible for randomization will be
included in a registry.
The first objective of this exploratory randomized study is to assess in patients with heart
failure and T2DM if a standard anti-diabetic strategy which includes insulin has a different
safety and efficacy profile than one without insulin. The number of patients to be included
in this exploratory pilot study will be insufficient to prove or disprove a statistically
significant beneficial effect of the two antidiabetic strategies on clinical events. Special
care will be paid to the biologic consistency of the different endpoints, primary and
secondary, even if none of them will individually yield statistically significant
differences.
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